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Document Control Specialist

Job Description:

The Document Control Specialist will be responsible for initiating, editing, and controlling documents and records according to procedures, standards, and regulations in an FDA regulated environment. Responsibilities will include updating and filing documents, logs, and databases in support of QMS activities. The individual will coordinate the review and revision of procedures, specifications, and forms, as well as obtain approvals. Additionally, the individual will prepare and process status reports, assign and monitor document numbers, and review documents for accuracy and completeness. They will also be responsible for the maintenance of electronic files to support the documentation control system.

Major Duties and Responsibilities:

  • Support the development of the document control system.
  • Coordinate the review and revision of procedures, specifications, forms, and other meetings as assigned.
  • Prepare reports, assign and monitor QA document and part numbers, and review documents for accuracy and completeness.
  • Maintain electronic files and paper files to support document control system.
  • File, retrieve, and maintain documents.
  • Receive, review, control, and track documents per relevant process and procedures.
  • Update and control documents, logs, and databases, while assigning part numbers and routing additions, deletions, and changes.
  • Control engineering notebook distribution and retrieval.
  • Identify and implement improvements to the document control system.
  • Train personnel on document format, content, use, control, and the document control system.
  • Support company goals, objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements.
  • Actively work to promote team building and morale within the company.
  • Perform other duties as assigned.

Education Requirements:

  • Bachelor Degree of equivalent experience/education.

Experience Requirements:

  • Minimum 1+ years of related experience in the medical device industry.
  • Preferred 3+ years of related experience in the medical device industry.

Additional Preferred Qualifications:

  • Thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, PowerPoint and Project.
  • Excellent verbal and written communication skills.
  • Ability to work independently.
  • Ability to build strong working relationships with multiple departments.
  • Experience with Class II medical devices.
  • HIGHLY PREFER CANDIDATES WITH START-UP EXPERIENCE.
  • Reports to: QA/RA manager.